The X-VISUAL (X-ray Visualized Indicator for Screw-strain Under Applied Load)

摘要 我们正在开发和传感器，X-可视(X-射线可视化的螺杆弯曲应用指示器 用于跟踪用于治疗髋部骨折的中空螺钉的骨折愈合情况。髋部骨折是一种主要的公众 住院死亡率高的健康问题。大约有330,000例髋关节固定手术 每年在美国演出一次。髋关节固定硬件的平均故障率约为5%，但增加到 超过20%的患者患有骨质疏松症、不稳定骨折和初始骨折不良等并存疾病 还原。当愈合延迟时，螺钉、其他五金件和骨骼可能会疲劳和失效，需要花费高昂的费用 对于这些虚弱的患者来说，翻修手术具有显著的发病率和死亡率风险。例如，1年期 手术后30天内再次入院的患者的全因死亡率为56%，而那些患者的全因死亡率为19% 没有重新入院。螺丝只有在加载时才会弯曲和切断，这种风险随着断裂而消失。 愈伤组织可以愈合并承担重任。因此，测量静载荷下的螺杆弯曲是一种理想的方法。 评估骨折愈合和失败风险。这改善了与患者和护理团队的沟通， 使正常康复的患者和理疗师对活动感到更舒服，同时 为缓慢康复的患者检测和避免病理改变。创新的是，X-VISION是第一个传感器 可以检测螺丝弯曲(和螺丝上的相关载荷)，这是一种很难执行的测量方法 其他方式，因为受限的几何图形。这种受专利保护的装置被设计成可以加载到螺丝中 在拆除导丝后，使用医疗保健中普遍存在的普通射线照相进行读取 设备，但通常对机械应变不敏感，并且通常在具有 到目前为止，非手术干预往往不起作用。使用之前的设计，我们演示了 用X射线测量锯骨标本、有限元模型、身体中螺钉弯曲的概念验证 样本，并跟踪绵羊的愈合情况。然而，旧的设计很难插入和阅读， 因此，这个第一阶段的提案设计了一个优雅的插件，带有增益机制和指示器上的读数 大头针。我们将在有限元计算模型、锯骨和身体中开发和测试设计 标本。为这项工作而聚集的临床、行业和学术合作伙伴有很强的 在骨科设备开发和测试方面的合作。他们汇集了测量方面的专业知识 系统、机械测试、医疗器械设计和整形外科。这项研究与以下方面有关 公共健康，因为它提供了一种非侵入性的方法来评估生物力学复位和术后 骨折愈合，以避免昂贵和危险的修改。

ABSTRACT We are developing and sensor, the X-VISUAL (X-ray Visualized Indicator for Screw bending Under Applied Load), to track fracture healing in canulated screws used to treat hip fractures. Hip fractures are a major public health concern with high in-hospital mortality rate. Approximately 330,000 hip fixation procedures are performed annually in the US. The average hip fixation hardware failure rate is around 5%, but increases to over 20% in patients with comorbidities such as osteoporosis, unstable fractures and poor initial fracture reduction. When healing is delayed, the screw, other hardware, and bone can fatigue and fail, requiring costly revision surgery with significant risk of morbidity and mortality for these frail patients. For example, the 1-year all-cause mortality rate for patients readmitted within 30 days of surgery is 56%, compared to 19% for those not readmitted. Screws only bend and cutout when they are loaded, and this risk disappears as a fracture callus heals and carries the load. Thus, measuring screw bending under standing load is an ideal way to assess fracture healing and risk failure. This improves communications with the patient and care team, enabling normally healing patients and physical therapists to feel more comfortable with activity, while detecting and avoiding pathologies for slowly healing patients. Innovatively, the X-VISUAL is the first sensor that can detect screw bending (and associated load on the screw), a measurement that is hard to perform in other ways because of the confined geometry. The patent protected device is designed to load into a screw after guidewire removal, and is read using plain radiography which is ubiquitously available in healthcare facilities but is usually insensitive to mechanical strain and usually detects pathologies when they have progressed so far that non-surgical interventions often don’t work. Using previous designs we demonstrated proof of concept for measuring screw bending with X-rays in Sawbones specimens, FEA models, cadaveric specimens, and tracked healing in a sheep. However, the old designs were cumbersome to insert and read, thus this Phase I proposal designs an elegant addon with a gain mechanism and readout on indicator along the pin. We will develop and test the design in FEA computational models, sawbones, and cadaveric specimens. The clinical, industry, and academic partners assembled for this work have a strong history of collaboration in orthopaedic device development and testing. They bring together expertise in measurement systems, mechanical testing, medical device design and orthopaedic surgery. The research is relevant to public health because, it provides a non-invasive means of assessing biomechanical reduction and postop fracture healing to avoid costly and risky revisions.